Investing in a Clinical Digital Analytics platform enables compliance with regulatory requirements and unlocks enhanced analytics for a leading pharmaceutical company.
The Client is an international Contract Research Organization (CRO) that integrates Clinical Development, Clinical Trial Supply, and Early Access Programs. This comprehensive approach allows the company to efficiently deliver transformative medicines to patients around the globe. Like all CROs, the Client is required to report the results of their clinical studies to the regulators in each country. Regulators stipulate that the data in such reports is sourced from a Validated Statistical Computing Environment (VSCE).
The Client lacked an in-house VSCE, so wanted to procure a system that would meet their current needs and grow with time. They came to Katalyze Data (then known as Amadeus Software) because of Katalyze’s previous experience of building such VSCEs for other CROs, and expertise in implementing analytics solutions based on SAS technology – the industry standard for this use case.
The development of the right VSCE solution for the Client required significant collaboration. The company needed a new “platform as a service” model to be defined, and to implement new policies, dividing responsibilities from a regulation and validation perspective.
Katalyze Data developed a SAS 9.4-based Office Analytics- and R-based VSCE, running in an Infrastructure-as-a-Service pattern on the Microsoft Azure cloud.
Katalyze Data worked alongside the Client to establish a new pharmaceutical validation pack, covering planning, requirements, design, testing, and reports. This was then used by Katalyze Data’s expert validation consultants to confirm compliance with regulatory requirements, including the FDA’s 21CFR Part 11 ‘electronic records, electronic signatures’ regulation.
Katalyze Data’s pharmaceutical industry consultants also performed a gap analysis on the Client’s existing Standard Operating Procedures and Work Instructions for the use of a VSCE and created documents to fill these gaps.
With the in-house SAS- and Microsoft Azure-based VSCE solution provided by Katalyze Data, the Client has revolutionised its data management strategy. New levels of control have been implemented while improving accessibility and functionality for users.
The client now has the flexibility they need to enable future growth, with the capabilities available to preserve compliance with strict industry standards for data governance and control.